KPS is looking for Oversight Monitor to join sponsor team. Small FTE approx 0.2 for this year. brThe primary responsibility of the (Clinical) Oversight Monitor (C)OM) is to ensure adequate Sponsor oversight of the conduct, monitoring and management of one or more clinical studies and assigned monitors at clinical study sites, within the assigned country or region. brThe (C)OM): brcontributes to development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan. brcontributes to the definition of appropriate standards and quality indicators for site management and monitoring. brensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards. braddresses issues identified with study conduct, monitoring and site management with Sponsor's management, are appropriately communicated/escalated and follows up through resolution. brMay conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed. brreviews the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region. brmay assist with translations or verification of translations. brimplements approved communication plans with external strategic partners or CROs. brsupports the collection of key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality. brreviews monitoring visit reports for finalization/consistency/issues according to study monitoring plan. brutilizes available tools/systems to assess vendor and site performance. brensures inspection readiness at the study sites and follow up corrective/preventive actions. brmaintains good communication and working relationships with investigators, internal stake-holders and external services providers (CROs). brprovide input into study feasibility for assigned sites/countries/region and supports the on-time delivery of a clinical study data, globally (if applicable) The (C)OM) Will Have: brcomputer literacy in appropriate software(s). brthe ability to work well within a matrix environment with excellent interpersonal (written and verbal) and decision-making skills. brdemonstrated innovation skills, drive, energy and enthusiasm to deliver the study program objectives. brdemonstrated management of all clinical study aspects (developing a protocol to clinical study report). brthe ability to identify, solve and escalate issues that arise at study sites and within site management brcomprehensive/extensive knowledge of ICH guidelines/GCP and remains current on medical/scientific aspects. brdemonstrated project management skills i.e. (simultaneous management of multiple vendors, sites and studies. Possesses excellent planning, time management and coordination skills. brdemonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies. The (C)OM) Will Have: bra degree (BSc/MSc or equivalent preferred) in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area. brother degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist). bra minimum of 8+ years' relevant clinical research (or related) experience. br6+ years' experience in monitoring and site management of industry sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent). bra thorough understanding of the drug development and clinical trial process. brthe ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary. brthe ability to participate in preparation, conduct and follow up of audits and site inspections. bractive management experience of countries and sites in a region. brthorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.